FDA.reportPublic FDA data

MARS Monitor

Primary DI
37332414106936
Brand
MARS Monitor
Company
GAMBRO AB
Model
800437
Catalog number
800437
Device description
The MARS Monitor is a mechanical detoxification device used in conjunction with a renal replacement therapy system (companion device) for the removal of dialyzable (unbound) toxins, which are either water-soluble or, in the bound form, associated with serum albumin.
Published
2015-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLDApparatus, Hemoperfusion, Sorbent
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLDApparatus, Hemoperfusion, SorbentGastroenterology, Urology2
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414106936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3733241410693637332414106936

GMDN Terms#

Term, Definition table
TermDefinition
Bound solute dialysis system pump/monitorA mains electricity (AC-powered) device that is a component of a bound solute dialysis system and used to control the circulation of a high-concentration albumin dialysate through a filter, to bind and remove albumin-bound toxins (e.g., bile acids, bilirubin, heavy metals, phenols) from a patient's blood during extracorporeal blood purification, typically in persons suffering liver failure or poisoning/drug overdose. It uses a dedicated set of filters, tubing, and connectors and may be controlled by dedicated application software.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify00Atmospheric Air Pressure between 500 and 1060 millibar, Relative Humidity is non-condensing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
354021099
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414124519AK 989556079556072021-03-22
07332414126766PRISMAFLEX7.219557922019-02-28
07332414105266Prismaflex5.XX1130812015-10-17
37332414127214CLCA - CLEANCART A9558509558502023-12-01
37332414127221CLCC - CLEANCART C9558519558512023-12-01
37332414107728MARS TREATMENT KIT TYPE 1116/1 - X-MARS US8005418005412017-10-26
37332414106950Mars Treatment Kit8004808004802015-06-08
07332414117702Prismaflex7.XX1152692015-10-09
07332414124236Prismaflex7.209555422017-11-24
37332414088317BiCart7201097332015-09-24
37332414110575BiCart12501140142015-09-24

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08056992333574HPH-1000 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
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08056992333604HPH-1000TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
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